Skill · em Documentar e entregar

regulatory-affairs-head

Senior Regulatory Affairs Manager expertise for HealthTech and MedTech companies. Provides strategic regulatory guidance, submission management, regulatory pathway analysis, global compliance coordination, and cross-functional team leadership. Use for regulatory strategy development, submission…

Procedência

Antes de instalar

5 arquivos · 21,1 KB · inclui 1 script que executa: scripts/regulatory_tracker.py

Instalar na sua CLI

O comando baixa a versão fixada (commit 57f899e) direto da origem, para a pasta que a CLI lê. Precisa de curl (macOS e Linux); no Windows não há comando, porque o Rook Labs é para macOS.

Claude Code

Neste projeto: instala em .claude/skills/regulatory-affairs-head/.

d=".claude/skills/regulatory-affairs-head"
u="https://raw.githubusercontent.com/davila7/claude-code-templates/57f899e5394bb8ca166f38eacae8f0853cbfe033/cli-tool/components/skills/enterprise-communication/regulatory-affairs-head"
curl -fsSL --create-dirs \
  -o "$d/SKILL.md" "$u/SKILL.md" \
  -o "$d/assets/example_asset.txt" "$u/assets/example_asset.txt" \
  -o "$d/references/eu-mdr-submission-guide.md" "$u/references/eu-mdr-submission-guide.md" \
  -o "$d/references/fda-submission-guide.md" "$u/references/fda-submission-guide.md" \
  -o "$d/scripts/regulatory_tracker.py" "$u/scripts/regulatory_tracker.py" \
  -o "$d/LICENSE" "https://raw.githubusercontent.com/davila7/claude-code-templates/57f899e5394bb8ca166f38eacae8f0853cbfe033/LICENSE"

Global: instala em ~/.claude/skills/regulatory-affairs-head/.

d="$HOME/.claude/skills/regulatory-affairs-head"
u="https://raw.githubusercontent.com/davila7/claude-code-templates/57f899e5394bb8ca166f38eacae8f0853cbfe033/cli-tool/components/skills/enterprise-communication/regulatory-affairs-head"
curl -fsSL --create-dirs \
  -o "$d/SKILL.md" "$u/SKILL.md" \
  -o "$d/assets/example_asset.txt" "$u/assets/example_asset.txt" \
  -o "$d/references/eu-mdr-submission-guide.md" "$u/references/eu-mdr-submission-guide.md" \
  -o "$d/references/fda-submission-guide.md" "$u/references/fda-submission-guide.md" \
  -o "$d/scripts/regulatory_tracker.py" "$u/scripts/regulatory_tracker.py" \
  -o "$d/LICENSE" "https://raw.githubusercontent.com/davila7/claude-code-templates/57f899e5394bb8ca166f38eacae8f0853cbfe033/LICENSE"

Codex

Neste projeto: instala em .agents/skills/regulatory-affairs-head/.

d=".agents/skills/regulatory-affairs-head"
u="https://raw.githubusercontent.com/davila7/claude-code-templates/57f899e5394bb8ca166f38eacae8f0853cbfe033/cli-tool/components/skills/enterprise-communication/regulatory-affairs-head"
curl -fsSL --create-dirs \
  -o "$d/SKILL.md" "$u/SKILL.md" \
  -o "$d/assets/example_asset.txt" "$u/assets/example_asset.txt" \
  -o "$d/references/eu-mdr-submission-guide.md" "$u/references/eu-mdr-submission-guide.md" \
  -o "$d/references/fda-submission-guide.md" "$u/references/fda-submission-guide.md" \
  -o "$d/scripts/regulatory_tracker.py" "$u/scripts/regulatory_tracker.py" \
  -o "$d/LICENSE" "https://raw.githubusercontent.com/davila7/claude-code-templates/57f899e5394bb8ca166f38eacae8f0853cbfe033/LICENSE"

Global: instala em ~/.agents/skills/regulatory-affairs-head/.

d="$HOME/.agents/skills/regulatory-affairs-head"
u="https://raw.githubusercontent.com/davila7/claude-code-templates/57f899e5394bb8ca166f38eacae8f0853cbfe033/cli-tool/components/skills/enterprise-communication/regulatory-affairs-head"
curl -fsSL --create-dirs \
  -o "$d/SKILL.md" "$u/SKILL.md" \
  -o "$d/assets/example_asset.txt" "$u/assets/example_asset.txt" \
  -o "$d/references/eu-mdr-submission-guide.md" "$u/references/eu-mdr-submission-guide.md" \
  -o "$d/references/fda-submission-guide.md" "$u/references/fda-submission-guide.md" \
  -o "$d/scripts/regulatory_tracker.py" "$u/scripts/regulatory_tracker.py" \
  -o "$d/LICENSE" "https://raw.githubusercontent.com/davila7/claude-code-templates/57f899e5394bb8ca166f38eacae8f0853cbfe033/LICENSE"

Antigravity

Neste projeto: instala em .agents/skills/regulatory-affairs-head/.

d=".agents/skills/regulatory-affairs-head"
u="https://raw.githubusercontent.com/davila7/claude-code-templates/57f899e5394bb8ca166f38eacae8f0853cbfe033/cli-tool/components/skills/enterprise-communication/regulatory-affairs-head"
curl -fsSL --create-dirs \
  -o "$d/SKILL.md" "$u/SKILL.md" \
  -o "$d/assets/example_asset.txt" "$u/assets/example_asset.txt" \
  -o "$d/references/eu-mdr-submission-guide.md" "$u/references/eu-mdr-submission-guide.md" \
  -o "$d/references/fda-submission-guide.md" "$u/references/fda-submission-guide.md" \
  -o "$d/scripts/regulatory_tracker.py" "$u/scripts/regulatory_tracker.py" \
  -o "$d/LICENSE" "https://raw.githubusercontent.com/davila7/claude-code-templates/57f899e5394bb8ca166f38eacae8f0853cbfe033/LICENSE"

Global: instala em ~/.gemini/antigravity-cli/skills/regulatory-affairs-head/.

d="$HOME/.gemini/antigravity-cli/skills/regulatory-affairs-head"
u="https://raw.githubusercontent.com/davila7/claude-code-templates/57f899e5394bb8ca166f38eacae8f0853cbfe033/cli-tool/components/skills/enterprise-communication/regulatory-affairs-head"
curl -fsSL --create-dirs \
  -o "$d/SKILL.md" "$u/SKILL.md" \
  -o "$d/assets/example_asset.txt" "$u/assets/example_asset.txt" \
  -o "$d/references/eu-mdr-submission-guide.md" "$u/references/eu-mdr-submission-guide.md" \
  -o "$d/references/fda-submission-guide.md" "$u/references/fda-submission-guide.md" \
  -o "$d/scripts/regulatory_tracker.py" "$u/scripts/regulatory_tracker.py" \
  -o "$d/LICENSE" "https://raw.githubusercontent.com/davila7/claude-code-templates/57f899e5394bb8ca166f38eacae8f0853cbfe033/LICENSE"

Peça ao Rook

Já usa o Rook Labs? Cole no chat do Rook: instale a skill https://rooklabs.sh/marketplace/cct.regulatory-affairs-head

Prévia do SKILL.md

---
name: regulatory-affairs-head
description: Senior Regulatory Affairs Manager expertise for HealthTech and MedTech companies. Provides strategic regulatory guidance, submission management, regulatory pathway analysis, global compliance coordination, and cross-functional team leadership. Use for regulatory strategy development, submission planning, r…
---

# Senior Regulatory Affairs Manager (Head of Regulatory Affairs)

Expert-level regulatory affairs leadership for HealthTech and MedTech companies with deep knowledge of global regulatory frameworks, submission strategies, and cross-functional team coordination.

## Core Competencies

### 1. Strategic Regulatory Planning
Develop comprehensive regulatory strategies that align with business objectives and ensure successful market access.

**Key Activities:**
- Regulatory pathway analysis and optimization
- Market access timeline development
- Resource allocation and budget planning
- Competitive regulatory landscape analysis

### 2. Regulatory Submission Management
Lead all aspects of regulatory submissions from pre-submission through post-market surveillance.

**Submission Workflow:**
1. **Pre-submission Strategy**
   - Conduct regulatory authority consultations
   - Define submission scope and timeline
   - **Decision Point**: Choose optimal submission pathway (De Novo, 510(k), PMA, MDR CE, etc.)

2. **Submission Preparation**
   - **For EU MDR**: Follow references/eu-mdr-submission-guide.md
   - **For FDA**: Follow references/fda-submission-guide.md  
   - **For ISO Requirements**: Follow references/iso-regulatory-requirements.md
   - **For Global Markets**: Follow references/global-regulatory-pathways.md

3. **Submission Review and Approval**
   - Manage regulatory authority communications
   - Coordinate responses to regulatory questions
   - Monitor approval timelines and dependencies
…

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